Dataset Information

NAVKIDS² trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.

ABSTRACT:

Background

This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS² trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published.

Methods/design

The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1-2, broadening of financial status eligibility criterion, addition of patients living in rural/remote areas, modification of age eligibility to 0-16 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis.

Trial registration

Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618001152213 . Prospectively registered on 12 July 2018.

SUBMITTER: van Zwieten A

PROVIDER: S-EPMC9522454 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

NAVKIDS<sup>2</sup> trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.

van Zwieten Anita A Ryan Elizabeth G EG Caldwell Patrina P Howard Kirsten K Tong Allison A Craig Jonathan C JC Alexander Stephen I SI Howell Martin M Teixeira-Pinto Armando A Hawley Carmel M CM Jesudason Shilpanjali S Walker Amanda A Mackie Fiona F Kennedy Sean E SE McTaggart Steven S McCarthy Hugh J HJ Carter Simon A SA Kim Siah S Woodleigh Reginald R Francis Anna A Mallard Alistair R AR Bernier-Jean Amélie A Johnson David W DW Hahn Deirdre D Reidlinger Donna D Pascoe Elaine E Varghese Julie J Kiriwandeniya Charani C Vergara Liza L Larkins Nicholas N Macauley Luke L Irving Michelle M Khalid Rabia R Guha Chandana C Wong Germaine G

Trials 20220930 1

<h4>Background</h4>This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS<sup>2</sup> trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published.<h4>Methods/design</h4>The original protocol was published in BMC Nephrology ( https://doi.org/10.1186/s12882-019-1325-y ) prior to the commencement of t ...[more]

PMID: 36175942

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Dataset Information

NAVKIDS² trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.

Background

Methods/design

Trial registration

Publications

NAVKIDS<sup>2</sup> trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.

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Dataset Information

NAVKIDS2 trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.

Background

Methods/design

Trial registration

Publications

NAVKIDS<sup>2</sup> trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

NAVKIDS² trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease - statistical analysis plan and update to the protocol.